Standard Historical Last Updated: Nov 28, 2014 Track Document
ASTM F881-94(2006)

Standard Specification for Silicone Elastomer Facial Implants

Standard Specification for Silicone Elastomer Facial Implants F0881-94R06 ASTM|F0881-94R06|en-US Standard Specification for Silicone Elastomer Facial Implants Standard new BOS Vol. 13.01 Committee F04
$ 66.00 In stock

Abstract

This specification covers the requirements for silicone elastomer implants used in facial surgery, that is, chin, nasal, malar, and ear implants. The primary material of construction shall be fully vulcanized silicone elastomer. Implants may have orientation means or sites of attached fixation materials, or both. Different tests shall be conducted in order to determine the following properties of elastomers: elongation at failure, tensile strength, modulus, and tear.

Scope

1.1 This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).

1.2 Limitations This specification does not cover implants containing silicone gels or other gels or liquids. It does not necessarily cover any custom-fabricated prosthesis manufactured to any other specification.

The following safety hazards caveat pertains only to the mechanical testing and test methods portion, Section 7, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Price:
Contact Sales
Related
Reprints and Permissions
Reprints and copyright permissions can be requested through the
Copyright Clearance Center
Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.32
Pages: 3
DOI: 10.1520/F0881-94R06
ICS Code: 11.040.40